principal Statistical programmer

Clinvia; San Francisco (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Clinvia is seeking a Principal Statistical Programmer to lead data analysis and contribute to statistical analysis plans. This position requires a strong background in SAS programming and at least 8 years of experience in the Pharmaceutical/Biotech sector.

The role will involve creating CDISC SDTM and ADaM files, as well as ensuring data quality and compliance for NDA submissions. Candidates should have a BS/MS in Statistics or a related field.

Qualifications

• Minimum 8 years Pharmaceutical/Biotech programming experience.
• NDA submission experience and knowledge required.
• Strong SAS programming and Statistical background.

Responsibilities

• Lead project level activities and perform data analysis.
• Create CDISC SDTM and ADaM files for electronic submissions.
• Contribute to statistical analysis plans and collaborate with clinical teams.

Skills

SAS programming

Statistical analysis

Data analysis

Education

BS/MS in Statistics, Math or Scientific Discipline

Tools

SAS Base

SAS/Macros

SAS/Graph

SAS/Stat

Job description

Principal Statistical Programmer

Responsibilities

• Project lead level activities.
• Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
• Create CDISC SDTM and ADaM files, SAS export files and Define.xml usage for electronic submission from data received in non-standard form from various sources.
• Performs data analysis, statistical analysis, generates safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
• Review Data Management Plan, Data validation plan and edit check specifications.
• Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate outputs according to the requirements.
• Implements and contributes to statistical analysis plans; provides expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
• Recognizes inconsistencies and initiates resolution of data problems.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
• Acts independently to determine methods and procedures on new assignments.
• May provide guidance to other lower level personnel.
• Works closely with Biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP).
• Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
• Create/acquire tools to improve programming efficiency or quality.
• Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
• Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.

Experience

• Minimum 8 years Pharmaceutical/Biotech programming experience.
• NDA submission experience and knowledge required.
• Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
• BS/MS in Statistics, Math or Scientific Discipline.

Work Location: Onsite in San Francisco Bay Area, CA